11 2013 - partnership for safe medicines€¦ · 23. defendantsyed huda, also known as "farhan...

IN THE UNITED STATES DISTRICT COURT FOR THE

EASTERN DISTRICT OF VIRGINIA 'Alexandria Division

UNITED STATES OF AMERICA

GALLANT PHARMA

INTERNATIONAL INC.,TALIB KHAN,SYED HUDA (a/k/a "Farhan Huda"),DEEBA MALLICK,MUNAJJ ROCHELLE,ROBERT WACHNA,HARVEY WHITEHEAD,PATRICIA DURR,LISA CORONITI,MIRWAISS AMINZADA, andANOUSHIRVAN R. SARRAF,

Defendants.

UNDER SEAL

Criminal No. 1:13CR130

Count 1: 18 U.S.C. § 371-Conspiracy

Counts 2-3: 18 U.S.C. § 545 - ImportationContrary to Law

Counts 4-8: 21 U.S.C. § 331(a) - Introductionof Misbranded Drugs

Counts 9-13: 21 U.S.C. § 331(t) - UnlicensedMedical Wholesaling

Counts 14-15: 18 U.S.C. § 1343 - Wire Fraud

Counts 16-17: 18 U.S.C. § 1957(a) - MonetaryTransactions With Criminally Derived Proceeds

Notice of Forfeiture

11 2013

CLERK. US. DIST '̂i

INDICTMENT

MARCH 2013 TERM - at Alexandria, Virginia

THE GRAND JURY CHARGES THAT:

GENERAL ALLEGATIONS

At all times relevant to this Indictment:

1. The Food and Drug Administration ("FDA") was the agency of the United States

responsible for regulating the manufacture, labeling, and distribution of drugs in the United

States. Among other things, the FDA was responsible for enforcing the provisions of the Federal

Case 1:13-cr-00130-CMH Document 1 Filed 03/27/13 of 27 PageID# 1

Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 e/ seq. ("FDCA"), includingregulating the

wholesale distribution of prescription drugs.

2. A "drug" was defined by the FDCA as, among other things, any article intended

for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other

animals; articles (other than food) intended to affect the structure or any function of the body of

man or other animals; and articles intended for use as a component of any such articles. See 21

U.S.C. § 321(g).

3. A "biological product" was defined by the Public Health Service Act ("PHSA")

as "a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative,

allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any

other trivalentorganicarsenic compound) applicable to the prevention, treatment,or cure of a

disease or condition of human beings." 42 U.S.C. § 262(i). A biological product could be

classified as a drug, dependingon its mode ofaction and intendeduse. The FDCAapplied to

biological products subject to regulation under the PHSA. See 42 U.S.C. § 262(j).

4. A prescription drug was defined by the FDCA as "a drug intended for use by man

which becauseof its toxicityor other potentiality for harmful effect, or the methodof its use, or

the collateral measures necessary to its use, is not safe except under the supervision ofa

practitioner licensed by law to administer such drug." 21 U.S.C. § 353(b)(1)(A). A drug may

also be limited to prescription use by its FDA-approved application. See 21 U.S.C.

§ 353(b)(1)(B).

5. The distribution of prescription drugs in the United States was regulated by the

FDA and was subject to a series of strict controls. To prevent prescription drug diversion and the


introduction of counterfeit, stolen, or substandard drugs into interstate commerce, Congress

enactedthe Prescription Drug MarketingAct ("PDMA"),which it incorporated into the FDCA.

6. Under the PDMA, no person could engage in the wholesale distribution in

interstate commerce of prescription drugs in a State unless such personwas licensed by the State.

See 21 U.S.C. §§ 353(e)(2)(A). FDA regulations set forth the minimum standards, terms, and

conditions for the state licensing ofwholesale prescription drug distributors, including guidelines

for the storage and handling of such drugs and for the establishment and maintenance of records

regarding the distributions of such drugs. See 21 U.S.C. § 353(e)(2)(B); 21 C.F.R. §§ 205.5,

205.50,206.6. The regulations further provided that wholesale prescription drug distributors

were required to permit State licensing authorities and authorized Federal, State, and local law

enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their

records and written operating procedures. 21 C.F.R. § 205.50(i).

7. The PDMA also required that each person engaged in the wholesale distribution

of prescription drugs who is not themanufacturer or authorized distributor of record of such drug

shall haveprovided to the personwho receives the drug, beforeeach wholesale distribution, a

statement identifying each prior sale, purchase, or trade ofsuch drug (includingthe date of the

transaction and the names and addresses of all parties to the transaction). See 21 U.S.C.

§ 353(e)(1)(A).This is known as the "pedigree" requirement.

8. Before a new drug could be introduced into interstate commerce, it must have

been the subject ofan approved application filed with the FDA. See 21 U.S.C. § 331(d), 355(a).

FDA approval was not for the molecular entity itself (i.e. the active ingredient) but included the

labeling. See 21 C.F.R. § 314.50(i).


9. The FDCA prohibited the introduction, and delivery for introduction, into

interstate commerce of any drug that was misbranded. See 21 U.S.C. § 331(a).

10. A drug was misbranded if, among other things, its labeling lacked adequate

directions for use. See 21 U.S.C. § 352(f)(1). By regulation, the FDAdefined"adequate

directions for use" to mean directions "under which the layman can use a drug safely and for the

purpose for which it is intended." 21 C.F.R. § 201.5 (emphasis added). Prescription drugs could

never contain adequate directions for lay use and were therefore misbranded unless they

qualified for an exemption. A prescription drug was exempt from Section 352(f)(1) if (1) the

drug was in the possession of a person regularly and lawfully engaged in the manufacture,

transportation, storage, or wholesale distribution of prescription drugs; and (2) the labelingon or

withinthe package from which the drug was to be dispensed bore the statement"Rx Only"and

was the labeling authorized by the FDA-approved new drug application. See 21 C.F.R.

§§ 201.100 (a)(l)(i), (b)(1), (c)(2).

11. The United States Customs and Border Protection ("CBP"), and Immigration and

Customs Enforcement, Homeland Security Investigations ("ICE-HSI"), two agencies within the

United States Department of Homeland Security ("DHS"), were the federal agencies responsible

for administering and enforcing violations of the laws governingthe importation into the United

States ofgoods and merchandise, including drugs.

GALLANT PHARMA

12. Defendants TALIB KHAN, SYED HUDA, DEEBA MALLICK, MUNAJJ

ROCHELLE, HARVEY WHITEHEAD, ROBERT WACHNA, PATRICIA DURR, LISA

CORONITI, MIRWAISS AMINZADA, and ANOUSHIRVAN R. SARRAF, and others known

and unknown to the Grand Jury, were associated with GALLANT PHARMA


INTERNATIONAL INC. ("GALLANT PHARMA"), a company engaged in the illegal

importation and sale of misbranded drugs in the United States. Between August2009 and

November 2011, the Defendants generated at least $3.3 million from the sale of misbranded

drugs to at least 54 doctors, medical practices, and hospitals in the United States.

13. GALLANT PHARMA maintained a website at www.gallantpharma.com. which

represented that GALLANT PHARMA was a wholesale distributor of"Brand Name and Generic

products" for cosmetic surgery, plastic surgery, dermatology, pain management, neurology,

anesthesiology, and oncology. The website directed visitors to submit a web-based inquiry form

to obtain a full product list. The website stated that GALLANT PHARMA provided customers

with free next-day shipping via Federal Express ("FedEx"), and accepted payment via credit

card, wire transfer, check and money order.

14. From in or about August 2009 until at least March 2013, GALLANT PHARMA

illegally imported and soldat least the following drugs:

Product

Alimta

Anzemet

Botox

DysportEloxatin

Faslodex

Gemzar

HerceptinMabThera

Taxotere

Velcade

Xeomin

Zometa

Use

Injectable chemotherapy for lung cancerAnti-nausea treatment for surgery and chemotherapy patientsInjectable treatment for forehead wrinklesand eye muscle disordersInjectable treatment for forehead wrinklesand abnormal head position/neck painInjectable chemotherapy for colorectal cancerInjectable chemotherapy for breast cancerInjectable chemotherapy for breast, lung, pancreatic, and ovarian cancerInjectable chemotherapy for breast cancerInjectable chemotherapy for non-Hodgkin's lymphomaInjectable chemotherapy for lung and breast cancerInjectable chemotherapy for multiple myeloma patientswho havealready hadseveral unsuccessful courses of treatment

Injectable treatment for cervical dystonia and blepharospasmInjectable treatment for bone tumors and hypercalcemia

15. GALLANT PHARMA was not licensed as a prescription drug wholesaler by the

Commonwealth of Virginia.


16. At times, sales by GALLANT PHARMA were conducted under the name of

Harmanda LLC. Harmanda was not licensed as a prescription drug wholesaler by the Stateof

Michigan or the Commonwealth ofVirginia.

17. Members of the conspiracy arranged for foreign co-conspirators to shipdrugs

intended for GALLANT PHARMA to the United Kingdom and Canada. Co-conspirators in the

United Kingdom and Canada then shipped the drugs to the United States using Royal Mail and

Canada Post. The Royal Mail and Canada Post both feed into the United States Postal Service

("USPS") for delivery in the United States and are generally subjected to less scrutiny by CBP

than shipments arriving from other countries.

18. Co-conspirators in the United Kingdom and Canada would also break large

packages into severalsmaller packagesbefore sendingto the United States. The packages would

be accompanied by Customs declarations that would include misleading information aboutthe

shipment, suchas an understated dollar valueor a misleading description of contents. Many

packages were addressed and delivered to Defendant ANOUSHIRVAN R. SARRAF at his

medical practice in McLean, Virginia, in the Eastern District ofVirginia, rather than to

GALLANT PHARMA.

19. The Defendants established an account with at least one credit card merchant

processor in the United States, Elevon, whichcollected sales revenue from GALLANT

PHARMA customers on GALLANT PHARMA's behalf. Members of the conspiracy

misrepresented to Elevonthat GALLANT PHARMA sold medical supplies such as pillows,

gowns, and patches.

20. Members of the conspiracy represented to Elevon that GALLANT PHARMA was

a Canadian company and directed Elevon to deposit sales proceeds directly into Canadian bank


accounts. Members of the conspiracy also paidGALLANT PHARMA expenses in the United

States with a check drawn on one of those Canadian bank accounts. In actuality, however, at all

times relevant to this Indictment, GALLANT PHARMA was headquartered in theEastern

District of Virginia.

Defendants

21. Defendant GALLANT PHARMA was a corporation engaged in the illegal

importation of misbranded drugs for distribution and sale to doctors, medical practices, and

hospitals in the United States. GALLANT PHARMA was registered under the laws of Canada

on or about August 29, 2009. The registered agent of GALLANT PHARMA was Defendant

SYED HUDA, under his commonly used name "Farhan Huda", at an address in Oakville,

Ontario. GALLANT PHARMA had two directors: Defendant SYED HUDA and an unindicted

co-conspirator. GALLANT PHARMA's United States business was headquartered at the

apartment of Defendants SYED HUDA and DEEBA MALLICK, in Crystal City, Virginia, in the

Eastern District ofVirginia. From on or about June 15, 2012, until at least March 2013,

GALLANT PHARMA leased office space in Springfield, Virginia, in the Eastern District of

Virginia.

22. Defendant TALIB KHAN, a citizen of Canada and a resident ofCanada and

Barbados, was a principal of GALLANT PHARMA. KHAN was the primary person engaged in

sourcing foreign drugs for importation into, and sale in, the United States.

23. Defendant SYED HUDA, also known as "Farhan Huda", a citizen of Canada and

a resident of Crystal City, Virginia, in the Eastern District ofVirginia, was another principal of

GALLANT PHARMA. HUDA had primary responsibility for GALLANT PHARMA's day-to

day operations in the United States. GALLANT PHARMA's United States headquarters were


located at HUDA's apartment in Crystal City, Virginia, inthe Eastern District of Virginia. From

on or about June 15,2012, until at leastMarch 2013, HUDA leased officespacefor GALLANT

PHARMA in Springfield, Virginia, in the EasternDistrictofVirginia.

24. Defendant DEEBA MALLICK, a United States citizenand a resident of Crystal

City, Virginia, in the Eastern District of Virginia, was the wife of HUDA, and resided with

HUDA at GALLANT PHARMA's United States headquarters. MALLICK handled order

shipmentand paymentprocessingfor GALLANT PHARMA, and was also involvedin sourcing

drugs from foreign co-conspirators.

25. From in or about September 2009 until at least November 2011, Defendant

MUNAJJ ROCHELLE, a dual citizen of Canada and the United States and a resident of Canada,

was a sales representative for GALLANT PHARMA with primary responsibility for California.

ROCHELLE was also involved in training new GALLANT PHARMA sales representatives.

26. Defendant ROBERT WACHNA, a citizen and resident of Canada, was a sales

representative for GALLANT PHARMA, with primaryresponsibility for the Orlando and

upstate New York regions.

27. From in or about July 2010 until at least March 2013, Defendant HARVEY

WHITEHEAD, a United States citizen and resident of Michigan, was a sales representative for

GALLANT PHARMA, with primary responsibility for Michigan. WHITEHEAD was also the

owner ofHarmanda, a limited liability company formed under the laws of Michigan on or about

March 9,2011.

28. From in or about September 2010 until at least March 2013, Defendant

PATRICIA DURR, a United States citizen and resident ofFlorida, was a sales representative for


GALLANT PHARMA. At times, DURR had primaryresponsibility for the Boston, New York

City, and Florida regions.

29. From in or about May 2011 until at least March 2013, Defendant LISA

CORONITI, a UnitedStates citizen and resident of Pennsylvania, was a sales representative for

GALLANT PHARMA, with primary responsibility for the Philadelphia region.

30. Defendant MIRWAISS AMINZADA, a United States citizen and resident of

Canada, represented himself as the owner of Royal Canadian Imports and supplied misbranded

drugs to GALLANT PHARMA.

31. Defendant ANOUSHIRVAN R. SARRAF, a United States citizen and resident of

Rockville, Maryland, was a doctor and the owner ofa medical clinic in McLean, Virginia, in the

EasternDistrictof Virginia. SARRAFreceived importations in his and his clinic's name on

behalf of GALLANT PHARMA, and purchased misbranded drugs from GALLANTPHARMA.

32. The above background allegations are re-alleged and incorporated intoeach

Count of this Indictment as if fully set forth in each Count.


COUNT 1

(18 U.S.C. § 371 - Conspiracy)

THE GRAND JURY CHARGES THAT:

33. Beginning in or around August 2009, and continuing until at least March 2013, in

the Eastern District of Virginia and elsewhere, the defendants,

GALLANT PHARMA,

TALIB KHAN,

SYED HUDA,

DEEBA MALLICK,

MUNAJJ ROCHELLE,

HARVEY WHITEHEAD,

ROBERT WACHNA,

PATRICIA DURR,

LISA CORONITI,

MIRWAISS AMINZADA, and

ANOUSHIRVAN R. SARRAF

did knowingly and intentionally combine, conspire, confederate, and agree, with each other and

with other persons known and unknown to the Grand Jury, to:

(a) fraudulently and knowingly import and bring into the United States merchandise

contrary to law, in violation ofTitle 18, United States Code, Section 545, specifically

misbranded drugs in violation of Title 21, United States Code, Section 331(a);

(b) knowingly engage in the wholesale distribution in interstate commerce of prescription

drugs in the Commonwealthof Virginia without being licensed by the Commonwealthof

10


Virginiato do so, in violationofTitle 21, United States Code, Sections 331(t), 333(b)(1)(D), and

353(e)(2)(A);

(c) with the intent to defraud and mislead, introduce into interstate commerce misbranded

drugs in violation of Title 21, United States Code, Sections 331(a) and 333(a)(2);

(d) knowingly and with the intent to defraud, devise and intend to devise a scheme and

artifice to defraud, and to obtain money and property by means of false or fraudulent pretenses,

representations, and promises, and, for the purpose of executing such scheme and artifice,

transmit and caused to be transmitted wire communications in interstate and foreign commerce,

in violation of Title 18, United States Code, Section 1343; and

(e) defraud the United States and its agencies by impeding, impairing, and defeating the

lawful functions of the FDA to protectthe healthand safetyof the public by ensuring that drugs

distributed in the United States were safe and effective from the time of manufacturing to the

delivery to theentity thatsells or dispenses the product to the ultimate consumer or patient.

Ways, Manner, andMeans ofthe Conspiracy

In furtherance of the conspiracy, the Defendants and others known and unknown to the

Grand Jury employed, among others, the following manner and means:

34. It was partof the conspiracy that, beginning in or around August 2009, members

of theconspiracy would purchase from foreign co-conspirators drugs intended foruse in foreign

countries.

35. It was further part of the conspiracy that foreign co-conspirators located in

countries other than the United Kingdom and Canada would ship drugs intended for GALLANT

PHARMA to members of the conspiracy in the United Kingdom and Canada, at the direction of

members of the conspiracy.

II


36. It was further part of the conspiracy that members of the conspiracy in the United

Kingdom and Canada would ship drugs intended for GALLANT PHARMA to the Eastern

Districtof Virginia by Royal Mail and CanadaPost, respectively. This method ofshipment, and

transshipment, furthered the conspiracy because it allowed packages to be delivered through the

USPS with less scrutiny than would be applied to packages arriving from other countries.

37. It was further part of the conspiracy that members of the conspiracy in the United

Kingdom and Canada would break packages intended for GALLANT PHARMA into multiple

smaller shipments, or include misleading statements about the package contents and value, or

send packages to a recipientother than GALLANT PHARMA. These actions furthered the

conspiracy by misleading CBP and therefore causing CBP to apply lessenedscrutiny to the

packages.

38. It was further part of the conspiracy that members of the conspiracy addressed

misbranded drugs intended for GALLANT PHARMA to Defendant ANOUSHIRVAN R.

SARRAFat his medical practice in McLean, Virginia, in the Eastern District of Virginia.

39. It was further part of the conspiracy that, from in or about June 2012 until at least

March 2013, members of the conspiracy leased office space in Springfield, Virginia, under the

name ofGALLANT PHARMA.

40. It was furtherpart of the conspiracy that membersof the conspiracy caused

misbranded drugs to travel in interstatecommerce from the Eastern District of Virginiato at least

54 distinct doctors, medical practices, and hospitals across the United States.

41. It was further part of the conspiracy that members of the conspiracy caused at

least one credit card processor to establish a merchant account based on false statements, which

12


furthered the conspiracy by enabling members of the conspiracy to accept credit card payments

for sales ofmisbranded drugs.

42. It was further part of the conspiracy that members of the conspiracy caused the

proceeds ofcredit card paymentsto be transferred to bank accounts in Canada. Between April

2010 and January 2012, more than $1.9 million was transferred by one Visa and Mastercard

payment processor, Elevon, to Toronto Dominion Bank and Bank ofNova Scotia accounts held

in the name of GALLANT PHARMA INTERNATIONAL INC. This furthered the conspiracy

by concealing the conspiracy and its proceeds.

43. It was further part of the conspiracy that members of the conspiracy paid

GALLANT PHARMA expenses from a bank account held in Canada.

44. It was further part of the conspiracy that members of the conspiracy deposited

checkpayments from salesof misbranded drugs intoa Capital One bank account in Arlington,

Virginia, in the EasternDistrictofVirginia,held in the name of DefendantDEEBA MALLICK.

45. It was further part of the conspiracy that members of the conspiracy regularly

communicated with each other via e-mail about the acquisition, illegal importation, and sale of

misbranded drugs.

46. It was further part of the conspiracy that the conspiracy derived a direct financial

benefit from the illegal importation and sale of misbranded drugs. Between August 2009 and

November 2011, the Defendants generated at least $3.3 million from the sale of misbranded

drugs in the United States.

13


Overt Acts

47. It was further part of the conspiracy that the following acts in furtherance of and

to effect the objects of the above-described conspiracy were committed in the Eastern District of

Virginia and elsewhere:

a. On or about December 10,2009, HUDA sent an e-mail from the Eastern District

of Virginia to an employee at Elevon stating that GALLANT PHARMA sold "commodity type

items", including the following "sample list of items":

Compression garments - $100-$200Plastic Surgery healing kits - $120-5150Breast wrap healing patches - $50-$75Elevation pillows - $50-$ 100Cellulite Reduction creams and treatments - $50-51500

Home beauty devices - $300-$ 1000Scar Reduction creams $50-$80Consultation gowns and robes $80-5150

b. On or about April 15,2010, HUDA signed an Elevon merchant application form,

representing that GALLANT PHARMA sold"Medical supplies, creams, patches." HUDA

represented to be "President"and 50% ownerof GALLANT PHARMA.

c. On or about February 8,2011, KHAN sold two vials of misbranded Zometa and

one vial ofmisbranded Gemzar to a customer in Cary, North Carolina, in exchange for 51,400,

and therebycaused misbranded drugs to travel in interstate commerce from the EasternDistrict

ofVirginia.

d. On or about March 15,2011, HUDA sold twenty-three vials of misbranded

Botox, five vials of Juvaderm Ultra 3, four vials of Juvaderm Ultra 4, and five vials of Radiesse

to SARRAF, in the Eastern District ofVirginia, in exchange for $8,560.

e. On or about April 4,2011, HUDA telephoned Elevon from the Eastern District of

Virginia and represented that GALLANT PHARMA was "a broker between medical suppliers."

14


f. On or about April 6,2011, HUDAtelephoned Elevon from the EasternDistrictof

Virginia and statedthat Gallant Pharma was selling the same productsas whenthe Elevon

account was established. HUDA represented that Gallant Pharma had added some "skin care

products" and was considering a client request to begin selling medical equipment.

g. On or about May 18,2011, DURR sold five vials of misbranded Eloxatin to Dr.

TE in Natick, Massachusetts, in exchange for $4,250, and thereby caused misbrandeddrugs to

travel in interstate commerce from the Eastern District of Virginia.

h. On or about June 14,2011, WACHNA sold two vials of misbranded Botox to Dr.

RP in Winter Park, Florida, in exchange for $1,548, and thereby caused misbranded drugs to

travel in interstate commerce from the Eastern District of Virginia.

i. On or about June 23,2011, WHITEHEAD sold six vials ofmisbranded Alimta to

Dr. AS in Bloomfield Hills, Michigan, in exchange for $2,490, and thereby caused misbranded

drugs to travel in interstate commerce from the Eastern Districtof Virginia.

j. On or about August23,2011, CORONITI sold five vials of misbranded Eloxatin

to Dr. EA in Mt. Carmel, Pennsylvania, in exchange for $3,500, and thereby caused misbranded

drugs to travel in interstate commerce from the Eastern District of Virginia.

k. On or about September 15,2011, ROCHELLEsold three vials ofmisbranded

Zometa and four vials of misbranded Gemzar to Dr. DP in Oakland, California, in exchange for

$2,775, and thereby caused misbranded drugs to travel in interstate commerce from the Eastern


1. On or about September 19,2011, KHAN and AMINZADA sent a string of e-

mails regarding KHAN's request that AMINZADAmail misbranded drugs from Canada to the

Eastern District ofVirginia. KHAN instructed AMINZADA:

15


Bro ... you take the products to Canada Post and mail it with tracking. That's all. It'svery simple. There is a 2 day (if sending cold chain products) and a 4 daydelivery. Onlyput 10 to 20 units per box so the value of the box does not exceed 10k. For thedescription, simply write "Medical Devices." For the value of the merchandise, put$100.00.

In reply, AMINZADA asked: "who do we write as a shipper as we don't have pharma license

and telephone number." KHAN instructed: "Just put Royal Canadian Imports. In the last 2

years, not a single box has been seized by US Customs... so don't worry. For phone number,

just put your employee's cell phone number." AMINZADA then asked whether he could instead

mail the misbranded drugs to KHAN in the "bahamas". In reply, KHAN stated: "No good bro.

Virginia."

m. On or about September 21,2011, KHAN sent an e-mail to WHITEHEAD

explaining why a prescription drug sent from the Eastern District of Virginia to a doctor in

Michigan contained a stickerstating"For Clinical Trial":

Hello Harvey, Here is theexplanation from my supplier. This makes perfect sense. Seebelow:

The Roche agent cannot usually export Mabthera's, but if they adda small sticker to thevial stating, 'For Clinical Trial', then Roche main office does not mind them selling theproducts for export. This is only for theMabthera's. The products are notat all intendedfor clinical trial as you can see from the Certificate ofAnalysis. It is a simple smallstick-on sticker that the agenthas to place on the vial before theycan export it. A real clinicaltrial pack, as you know, does noteven come with an outer packaging; it is simply thevialwith imprinted onto the vial 'For Clinical Trial Number 12345" which carries the trialnumber and the address where the trial is taking place.

n. On or about September 23,2011, KHAN mailed ninety-eight (98) units of

misbranded Alimta lOOmg obtained from AMINZADA from Canada to the Eastern District of

Virginia, whichwere received by HUDAand MALLICK on or about September 25, 2011.

o. On or about September 26,2011, an unindicted co-conspirator in the United

Kingdom sentan e-mail to KHAN and another unindicted co-conspirator, stating in part: "Please

find attached the royal mail information for yourorderof Botox. Pleasecan you confirm receipt

16


of theorder." The e-mail attached a pdfdocument, which depicted two Royal Mail "Despatch

Receipts" containing information on thirteen (13) shipments. Thetop of each Despatch Receipt,

in the "Delivery address" column, contained SARRAF's name and the address of SARRAF's

medical practice in McLean, Virginia, in the Eastern Districtof Virginia. The subsequent lines

in the "Delivery address" column contained handwritten quotation marks.

p. On or about September 26,2011, HUDA replied to an e-mail from KHAN,

forwardingan e-mail exchange between KHAN and unindicted co-conspirators in the United

Kingdom. On September 23,2011, an unindicted co-conspirator in the United Kingdom had

written to KHAN, in relevant part:

I am writing with regard to your order for Hydrocortistab which we have been discussing.Due to the product being a prescription only medication, it will not be possible for us toship the product to the US at all. With Botox and Dysport it is possible as they can bepurchasedwithout a prescription, but, with prescription only medication, especially goinginto America, we need an actual prescription for the product to pass through customs.

In the forwarding message, KHAN wrote: "We'll have to get the HC through [an unindictedco

conspirator]. He said he should be able to get it." In reply, HUDA wrote: "Let me knowwhen

the HC is expected."

q. Onor about September 27,2011, KHAN sent an e-mail to WHITEHEAD,

DURR, HUDA, and ROCHELLE, with the subject line "FW: Alimta Photos." The e-mail read:

Hello all, Alimta seems to be a problem sourcing out of Europe in the short term. Thereis Turkish product available and I have attached the photos. Please let me know yourthoughts. If you and your clients are okay with this packaging, I can source itimmediately.

The e-mail containedphotographs ofproduct packaging and labels, which were written in a

language other than English.

r. On or about November 19,2011, MALLICK sent an e-mail to KHAN. The

subject line was "Avastin pic" and the signature line of the e-mail read "Sent from my HTC

17


smartphone on the Now Network from Sprint." A photograph was attached to the e-mail, and

the photograph depicted a label thatcontained writing in a language otherthan English.

s. On or about February 29,2012, MALLICK negotiated a check in the amount of

521,353.31 from a Capital One Bank account in Arlington, Virginia, in the Eastern District of

Virginia, held in the name of DEEBA MALLICK, made payable to Mercedes-Benz of

Alexandria, Virginia, in the Eastern District ofVirginia.

t. On or about June 6,2012, HUDA negotiated a check in the amount of $10,800

from a Bank ofNova Scotia account held in the name of GALLANT PHARMA

INTERNATIONAL INC., made payable to J&H LLC in Springfield, Virginia, in the Eastern


u. On or about June 15, 2012, HUDA entered into a lease with J&H LLC and

thereby rented officespace for GALLANT PHARMA in Springfield, Virginia, in the Eastern

District ofVirginia.

v. On or about August 10,2012, SARRAF received ten (10) packages on behalfof

GALLANT PHARMA at his medical practice in McLean, Virginia, in the Eastern District of

Virginia. The packages were sent from the United Kingdom via Royal Mail and were delivered

bythe USPS. The packages were addressed to SARRAF and the shipping documents indicated

that the packages contained "medical instruments" with a declared value of 500 GBP.

w. On or about August 10, 2012, an unindicted co-conspirator retrieved the

aforementionedpackages from SARRAF's medical practice in McLean, Virginia, in the Eastern

District of Virginia, on behalf of GALLANT PHARMA.

(All in violation ofTitle 18, United States Code, Section 371).

18


COUNTS 2-3

(18 U.S.C. § 545 - Importation Contrary to Law)

THE GRAND JURY FURTHER CHARGES THAT:

48. Thefactual allegations contained in Paragraphs 34 through 47 are re-alleged and

incorporated as if set forth here in their entirety.

49. On or about the dates set forth below, in the Eastern District of Virginiaand

elsewhere, the defendants listed below did fraudulentlyand knowingly import and bring into the

United States merchandise contrary to law, and receive, conceal, buy, sell, and facilitate the

transportation, concealment, and sale of, such merchandise after importation, knowing such

merchandise to have been imported and brought into the United States contrary to law, in that the

merchandise was a misbranded drug in violation of 21 U.S.C. § 331(a).

Count Approximate Date Merchandise Defendants2 September 23,2011 Misbranded Alimta from

AMINZADA, sent fromCanada by KHAN

GALLANT PHARMA,TALIB KHAN,SYED HUDA,DEEBA MALLICK,MIRWAISS AMINZADA, andANOUSHIRVAN R. SARRAF

3 September 26,2011 Misbranded Botox sent from

the United Kingdom by anunindicted co-conspirator

GALLANT PHARMA,TALIB KHAN,SYED HUDA,DEEBA MALLICK, andANOUSHIRVAN R. SARRAF

(All in violation ofTitle 18, United States Code, Sections 545 and 2).

19


COUNTS 4-8

(21 U.S.C. § 331(a)and 333(a)(2)- Introducing Misbranded Drugs Into Interstate Commerce)


50. The factual allegations contained in Paragraphs 34 through 47 are re-alleged and


51. On or about the dates listed below, in the Eastern District of Virginia and

elsewhere, defendants

GALLANT PHARMA,

TALIB KHAN,

SYED HUDA,

DEEBA MALLICK,

MUNAJJ ROCHELLE,

ROBERT WACHNA,

HARVEY WHITEHEAD,

PATRICIA DURR, and

LISA CORONITI,

with the intent to defraud and mislead, introduced, delivered for introduction, and caused the

introduction and delivery for introduction into interstate commerce, from the Eastern Districtof

Virginia to the locations listed below, the indicated drugs that were misbranded as defined in

Title 21, United States Code, Section 352(f)(1), in that the labeling did not bear adequate

directions for use.

Count Approximate Date Description ofIntroduction

4 May 18,2011 Shipment of five vials of misbranded Eloxatin to Dr. TE inNatick, Massachusetts, in exchange for $4,250

20


Count Approximate Date Description ofIntroduction

5 June 14,2011 Shipment of two vials of misbranded Botox to Dr. RP in WinterPark, Florida, in exchange for $1,548

6 June 23,2011 Shipment ofsix vials ofmisbranded Alimta to Dr. AS inBloomfield Hills, Michigan, in exchange for $2,490

7 August 23,2011 Shipment of five vials of Eloxatin to Dr. EA in Mt. Carmel,Pennsylvania, in exchange for $3,500

8 September 15,2011 Shipment of three vials ofmisbranded Zometa and four vials ofmisbranded Gemzar to Dr. DP in Oakland, California, inexchange for $2,775

(All in violation ofTitle 21, United States Code, Sections 331(a) and 333(a)(2), and Title 18,United States Code, Section 2).

21


COUNTS 9-13

(21 U.S.C. § 331(t) - Unlicensed Wholesale Distribution of Prescription Drugs)


52. The factual allegations contained in Paragraphs 34 through 47 are re-alleged and


53. On or about the dates listed below, in the Eastern District of Virginia, defendants

GALLANT PHARMA,

TALIB KHAN,

SYED HUDA,

DEEBA MALLICK,

MUNAJJ ROCHELLE,

ROBERT WACHNA,

HARVEY WHITEHEAD,

PATRICIA DURR, and

LISA CORONITI,

did knowingly engage in the wholesale distribution in interstate commerce of prescription drugs

without being licensed by the Commonwealth ofVirginia.

Count Approximate Date Description ofUnlicensedDistribution

9 May 18,2011 Shipment of five vials of misbranded Eloxatin to Dr. TE inNatick, Massachusetts, in exchange for $4,250

10 June 14,2011 Shipment of two vials of misbranded Botox to Dr. RP in WinterPark, Florida, in exchange for $1,548

11 June 23,2011 Shipment of six vials of misbranded Alimta to Dr. AS inBloomfield Hills, Michigan, in exchange for $2,490

12 August 23, 2011 Shipment of five vials of Eloxatin to Dr. EA in Mt. Carmel,Pennsylvania, in exchange for $3,500

22


Count Approximate Date Description ofUnlicensedDistribution

13 September 15,2011 Shipment of three vials of misbranded Zometa and four vials ofmisbranded Gemzar to Dr. DP in Oakland, California, inexchange for $2,775

(All in violation ofTitle 21, United States Code, Sections 331(t), 333(b)(1)(D), and353(e)(2)(A), and Title 18, United States Code, Section 2).

23


COUNTS 14-15

(18 U.S.C. § 1343 - Wire Fraud)


54. The factual allegations contained in Paragraphs 34 through 47 are re-allegedand


Object oftheScheme andArtifice to Defraud

55. The objects of the Conspiracy charged in paragraph 33 of Count 1 are re-alleged

and incorporated as if set forth here in their entirety to describe the objects of the scheme and

artifice to defraud.

Ways, Manner, and MeansoftheScheme andArtifice to Defraud

56. The Manner and Means of the Conspiracy section of Count 1 is re-alleged and

incorporated as if set forth here in its entirety to describe the scheme and artifice.

Execution ofthe Scheme andArtifice to Defraud

57. On or about the dates listed below, in the Eastern District ofVirginia and

elsewhere, defendants GALLANT PHARMA and SYED HUDA, for the purpose of executing

and attempting to execute the aforesaid scheme and artifice to defraud, did knowingly transmit

and cause to be transmitted wire communications in interstate and foreign commerce, as

indicated below.

Count Approximate Date Wire Communication

14 December 10,2009 E-mail from SYED HUDA to Elevon, including list of sample"commodity type" items sold by GALLANT PHARMA

15 April 4,2011 Telephone call from SYED HUDA to Elevon, representing thatGALLANT PHARMA was "a broker between medical

suppliers."

(All in violation ofTitle 18, United States Code, Section 1343)

24


COUNTS 16-17

(18 U.S.C. § 1957(a)- MonetaryTransaction With Criminally Derived Proceeds)


58. The factual allegations contained in Paragraphs 34 through47 are re-alleged and


59. On or about the dates listed below, in the Eastern District of Virginia, the

Defendants listed below did knowingly engage and attempt to engage in a monetary transaction

by through and to a financial institution, affecting interstate and foreign commerce, in criminally

derived property ofa value greater than $10,000, such property having been derived from

specified unlawful activity, that is, importation contrary to law, in violationofTitle 18, United

States Code, Section 545, and wire fraud, in violation of Title 18, United States Code, Section

1343.

Count Date Transfer Defendants

16 February 29,2012 Negotiation of check number 133 inthe amount of $21,353.31, drawn onCapital One account number7773206376 in the name of DEEBA

MALLICK, made payable toMercedes-Benz of Alexandria,Virginia.

DEEBA MALLICK

17 June 6,2012 Negotiation ofcheck number 240 inthe amount of USD $10,800, drawnon Bank ofNova Scotia account no.

0041416, in the name of GALLANTPHARMA International Inc., madepayable to J&H LLC.

GALLANT PHARMA

and SYED HUDA

(All in violation of Title 18, United States Code, Section 1957(a)).

25


NOTICE OF FORFEITURE

(18 U.S.C. § 981(a)(1)(C); 18 U.S.C. § 982(a)(1); 28 U.S.C. § 2461(c))

1. The allegations contained in Counts 1-3 and 14-17of this Indictment are hereby

realleged and incorporated by reference for the purpose of alleging forfeiture.

2. Pursuant to Federal Rule of Criminal Procedure 32.2(a), the United States of

America gives notice to the Defendants that, in the event of a conviction of any of the offenses

charged in Counts 1-3 and 14-17 of this Indictment, the United States intends to forfeit the

property further described in this NOTICE OF FORFEITURE.

3. A defendant who is convicted ofan offense in violation of 18 U.S.C. §§ 545 or

1343, or a conspiracy to violate 18 U.S.C. §§ 545 or 1343, shall forfeit to the United States of

America, pursuant to 18 U.S.C. § 981(a)(1)(C) and 28 U.S.C. § 2461(c), any property, real or

personal, which constitutes or is derived from proceeds traceable to such violation(s).

4. A defendant who is convicted of an offense in violation of 18 U.S.C. § 1957 shall

forfeit to the United States of America, pursuant to 18 U.S.C. § 982(a)(1), any property, real or

personal, involved in such violation, or any property traceable to such property.

5. The property to be forfeited includes, but is not limited to, the following:

a. $3.3 million in United States dollars;

b. Bank ofNova Scotia account no. 0041416, in the name of GALLANTPHARMA INTERNATIONAL INC.;

c. Toronto Dominion Bank account no. 02017305209, in the name ofGALLANT PHARMA INTERNATIONAL INC.;

d. Capital One Bank account no. 7773206376, in the name of DEEBAMALLICK;

26


e. 2012 Mercedes-Benz ML350W4 (VIN 4JGDA5HB6CA046380); and

f. 315 Sapphire Beach Condos, St. Lawrence Gap, Christ Church, Barbados.

6. If any of the property described above, as a result of any act or omission of

any defendant,

a. cannot be located upon the exercise ofdue diligence;

b. has been transferred or sold to, or deposited with, a third party;

c. has been placed beyond the jurisdiction of the court;

d. has been substantially diminished in value; or

e. has been commingled with other property which cannot be divided

without difficulty,

the United States ofAmerica shall be entitled to forfeiture of substitute property pursuant to Title

21, United States Code, Section 853(p), as incorporated by Title 18, United States Code,

Sections 982(b)(1) and Title 28, United States Code, Section 2461(c).

(All pursuant to 18 U.S.C. § 981(aXl)(C) and § 982(a)(1), and 28 U.S.C. § 2461(c))

NEIL H. MACBRIDE

UNITED STATES ATTORNEY

LINDSAY AIJKELLYASSISTANT UNITED STATES ATTORNEY

UhjI

27

A TRUE BILL:

I'suimns lo thc-r Govacnrnait Act,it*original ofthis pagp has bocn \'--:i

un^cr seal$< tfa? Clerk's (iflk..

Foreperson of the Grand Jury


11 2013 - partnership for safe medicines€¦ · 23. defendantsyed huda, also known as "farhan...

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